FDA affirms its commitment to efficient adoption of Risk Evaluation and Mitigation Strategy plans and to making sure they do not impede generic drug development


4 April 2019 - Today, the U.S. FDA issued guidance for industry, REMS: FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary. 

This guidance clarifies how FDA determines whether a REMS is necessary to ensure that the benefits of a drug outweigh its risks. 

It finalises the draft guidance, issued on 21 September 2016.

Read FDA statement

Michael Wonder

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Michael Wonder